MDCG guidance
MDCG 2021-21 Rev.1: Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
MDCG guidance · COVID-19 · February 2022
Key facts
| Reference | MDCG 2021-21 Rev.1 |
|---|---|
| Title | Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices |
| Topic | COVID-19 |
| Published | February 2022 |
| Document | health.ec.europa.eu |
At a glance
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- MDCG 2021-21 Rev.1 (February 2022) Revisions on file
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About MDCG guidance documents
The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.